HISTORICAL PROSPECTIVE

II. HISTORICAL PROSPECTIVE

It is useful to explore the historical antecedents of our current food safety law. They reveal how and why we adopted the new system that was put in place in the 1950s.

A. Ancient History to 1906

Ancient history is filled with examples of concern about, and resulting regulation of, food adulteration. From the dietary laws of Moses to the Roman statutes, through the remark- able laws enacted by Parliament in the Middle Ages, and culminating in the three statutes enacted in England during the third quarter of the 19th century, regulation of food safety has been regarded as an important function of every advanced government (1). In 1266, for example, Parliament prohibited a number of important staple food items if they were so adulterated as to be ‘‘not wholesome for Man’s Body’’ (2). In the intervening seven centuries, we have been unable to improve upon that remarkably clear, unambiguous, and completely descriptive statutory language. If it remained the law today, it would unques- tionably constitute sufficient authority for FDA to take all of the action it in fact does take every day to protect the safety of our food supply.

None of these early regulatory approaches relied upon anything other than govern- ment and industry policing the marketplace. There was no required premarket testing, premarket notification, premarket approval, registration of manufacturers, or listing of substances. It was incumbent on the government and the industry guilds to uncover in- stances of food adulteration and to punish the culprits.

B. 1906 to 1938

Our first national food and drug law, the Federal Food and Drugs Act of 1906 (3), similarly contained no provision for premarket notification, testing, or approval. Section 7 of the 1906 Act declared a food adulterated, and thus illegal, if was shown to ‘‘contain any added poisonous or other added deleterious ingredient which may render such article injurious to health.’’ The 1906 Act relied solely upon FDA and its predecessor agencies (4) exercising surveillance over the marketplace and taking adequate enforcement action to assure com- pliance with this.

But the seeds of premarket approval had already been sewn. As a result of two drug tragedies that occurred in 1901, when contaminated smallpox vaccine caused an outbreak of tetanus in Camden and eleven children were killed in St. Louis because of a contami- nated antitoxin, Congress enacted the Biologics Act of 1902 (5). This law required premar- ket approval of both a new biological product and the establishment in which it was to

be manufactured. Although that statute was enacted just four years before the Federal Food be manufactured. Although that statute was enacted just four years before the Federal Food

C. 1938 to 1950

No significant change was made in the authority of FDA to regulate food safety when Congress enacted the FD&C Act of 1938 (6). The basic statutory prohibition against added poisonous or deleterious substances remained unchanged from the 1906 Act (7). The 1938 Act, like its predecessor, relied completely upon FDA surveillance and enforcement in the marketplace.

Once again, the potential for premarket approval was lurking in the shadows. As a result of another drug tragedy, which killed more than a hundred people throughout the country in the fall of 1937, Congress included in the 1938 Act a requirement for premarket notification for all new drugs. No one suggested, however, that this approach be expanded to include the ingredients of food or the other products regulated under the new law.

D. The Delaney Committee of 1950 to 1952

During the first half of this century, relatively few functional ingredients were used in food. Following the explosion of food technology during World War II, however, there was a proliferation of functional food ingredients and a revolution in processed food. Representative Frank B. Keefe of Wisconsin was the first to introduce legislation to estab- lish a committee to investigate the use of chemicals in food products. Because Mr. Keefe was in the minority party, and in very poor health, he persuaded a young member of the House of Representatives, James J. Delaney of New York, to sponsor the resolution that was ultimately passed (8) and to serve as chairman of the committee.

The Delaney Committee, as it came to be known, investigated the use of chemicals in food, and later in cosmetics, for two years. In 1952, the Delaney Committee issued its report (9).

The Delaney Committee Report concluded that ‘‘there is a genuine need for the use of many chemicals in connection with our food supply.’’ It documented the introduction of new chemicals at an ‘‘ever-increasing rate.’’ The Food and Drug Administration testi- fied that approximately 842 chemicals had been used or suggested for use in food, 704 were actually used in food at that time, and the agency could make a definitive determina- tion of safety for only 428 of those substances. The report concluded that chemical addi- tives in food ‘‘raised a serious problem as far as the public health is concerned’’ and that existing laws ‘‘are not adequate to protect the public against the addition of unsafe chemicals.’’ Finally, ‘‘most witnesses’’ were reported to favor a law that would require that ‘‘a chemical or synthetic should not be permitted to be used in the production, pro- cessing, preparation, or packaging of food products until its safety for such use has been established’’ by the same type of premarket notification then required for new drugs.

Looking back, the language of the Delaney Committee Report is remarkably devoid of the inflammatory rhetoric to which we have become accustomed in the intervening years. No charges were made that the food industry was poisoning the American public. Rather, the committee concluded that the safety of the new ingredients being added to the food supply, and therefore the risk to the consuming public, was unknown and uncer- tain. This was enough, however, to frighten the public and to bring forth demands for

In the mid-1950s, in direct response to the Delaney Committee Report, the National Academy of Sciences (NAS) took a dispassionate look at the use of chemical additives in food processing (10). Noting that the ‘‘widely publicized Delaney Committee statement has caused apprehension as to the safety of processed foods,’’ the NAS report pointed out that many substances purposely added to the food supply have been used for centuries, come from natural sources, and serve important functional purposes. The report listed some 600 direct chemical additives for human foods, broken down by functional category.

Not surprisingly, Congress immediately began to consider new legislation. The re- sult was the enactment of three statutes in the next eight years to require premarket evalua- tion and approval of substances added to the food supply—the Miller Pesticide Amend- ments of 1954 (11), the Food Additives Amendment of 1958 (12) and the Color Additive Amendments of 1960 (13). These three statutes have dominated food safety issues in the intervening four decades. This chapter focuses on two of those three statutes—the laws regulating food additives and color additives.